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Analytical Scientist

Company: Comrise
Location: Warren
Posted on: November 20, 2022

Job Description:

Job Summary -The Analytical Scientist will be part of a team of drug development professionals responsible for the continued development and regulatory approval of thin film drug products containing a wide range of therapeutic compounds.
Job Responsibilities

  • Hands-on laboratory analysis of R&D drug substance and drug product samples.
  • Method development, method transfer and validation of analytical methods developed in-house or from client.
  • Provide analytical support during pre-formulation, formulation development and manufacture of prototype formulations, clinical trial materials and process scale-up.
  • Perform characterization, release and stability testing of raw material and drug product samples for conformance to specifications.
  • Prepare and update/review SOPs for the analytical laboratory.
  • Observe and maintain compliance with applicable DEA and safety regulations, cGLP/GMP guidelines, and Aquestive policies and procedures.
  • Interact in a team atmosphere, providing expertise in general analytical techniques.
  • Troubleshooting and repair of minor problems in analytical instruments.
  • Responsible for laboratory work area housekeeping.
  • Assist with raw data review, analysis, report writing and laboratory investigations (OOT/OOS).
  • Ensure that responses to regulatory inquiries are conducted in accordance with regulatory -guidelines and in consideration of business implications. -
    Job Qualifications
    • BS/MS in Chemistry. -
    • Minimum 3 - 5 years of pharmaceutical experience in an R&D analytical laboratory supporting small molecule, protein and peptide development programs
    • Strong analytical skills, proven experience in wet chemistry, HPLC, Dissolution, KF, GC and spectrophotometry
    • Thorough knowledge of cGMPs, compendia requirements, FDA and EMA regulations.
    • Experience working with and interpreting regulatory documents such as CFRs, FDA and ICH Guidance documents
    • Excellent written and oral communication skills with an ability to prepare and present concise technical data reports to non-scientific counterparts
    • Prior experience with FDA/EMA inspections and audits a plus
    • Proficiency in standard office software (MS Word, Excel, PowerPoint)
    • Must be detail oriented and organized with excellent documentation practices

Keywords: Comrise, Elizabeth , Analytical Scientist, Other , Warren, New Jersey

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